Press Release (ePRNews.com) - ATLANTA - Feb 10, 2020 - Florence, an Atlanta-based clinical trial software company, today announces the introduction of v0.9 of the Global Electronic Investigator Site File (eISF)/eRegulatory Binder Reference Model. This reference model was developed in collaboration with WCG MAGI and numerous clinical research technology experts to ensure interoperability between eISF platforms, eTMFs, and other systems.
MAGI, whose mission is to streamline clinical research by standardizing best practices for clinical operations, business, and regulatory compliance, assembled leading industry experts over the past 18 months to address the pressing need for consistent and streamlined data and document exchange.
“Patients can’t wait for us to exchange documents between electronic systems by email or through a host of one-to-one electronic communication tools. It has been truly remarkable how eISF competitors and other industry leaders have collaborated to create this common reference model,” said Norman M. Goldfarb, MAGI’s Founder and Chairman.
The steering committee included thought leaders, researchers and solution providers such as Florence, WCG, Complion, Realtime, MasterControl, Advarra, ICON, INC Research, LMK Research, Meridien Research, OHSU, PRA, Seattle Cancer Care Alliance, University of Pennsylvania, University of Washington and Vanderbilt University, among others.
At Florence, we believe in advancing research together,” said Ryan Jones, CEO of Florence. “Through this initiative, we not only expect to streamline connections between sponsors and our 6,300 Florence eBinders eISF sites, but we also hope to empower connections from other vendors as well. We’re seeking a measurable reduction in document work worldwide.”
“Interoperability between systems is key to advancing research,” said Jordan Tapley, Senior Solutions Engineer for Florence and project leader for the Reference Model. “Simply put, to make the biggest impact on accelerating research – driving down development costs and getting cures to patients faster – software platforms must be able to talk to each other securely.”
“As eISF platforms and eReg Binders become the standard at the research site, it is essential they all share common data structures,” says D’Anna Siegle, Product Marketing Manager for the eISF at Florence. “This is especially relevant as external stakeholders such as research sponsors access these systems and through integration, extract needed data and documents back to their eTMF platforms.”
Download the eISF/eReg Binder Reference Model at www.eISFModel.com. v0.9 will be reviewed by eISF vendors and research sites for finalization in version 1.0. The eISF/eReg Binder Reference Model maps directly to the DIA TMF Reference Model.